Curable material delivery device with a rotatable supply section

ABSTRACT

An apparatus and method for introducing material into an injection site of a patient is disclosed. The device includes a cannula and a carrier. The cannula is inserted into an injection site of a patient. The carrier is connected to an injector containing a volume of material. Material may be pre-loaded into the carrier so that the material is delivered to a distal end of the carrier from the injector and the carrier is thus pre-loaded with material. A portion of the distal end of the pre-loaded carrier is inserted into the cannula and material is delivered to an injection site. The supply section can be rotatable with respect to the longitudinal axis of the inner section.

RELATED APPLICATIONS

This application is a continuation-in-part of U.S. patent applicationSer. No. 11/359,184, entitled “Curable Material Delivery Device,” filedFeb. 22, 2006 now U.S. Pat. No. 7,922,690.

TECHNICAL FIELD

The present invention relates to devices and methods for stabilizingbone structures. More particularly, it relates to devices, systems andmethods for delivering a curable, stabilizing material into a bonestructure.

BACKGROUND INFORMATION

Surgical intervention at damaged or compromised bone sites has provenhighly beneficial for patients, for example patients with back painassociated with vertebral damage.

Bones of the human skeletal system include mineralized tissue that cangenerally be categorized into two morphological groups: “cortical” boneand “cancellous” bone. Outer walls of all bones are composed of corticalbone, which has a dense, compact bone structure characterized by amicroscopic porosity. Cancellous or “trabecular” bone forms the interiorstructure of bones. Cancellous bone is composed of a lattice ofinterconnected slender rods and plates known by the term “trabeculae.”

During certain bone procedures, cancellous bone is supplemented by aninjection of a palliative (or curative) material employed to stabilizethe trabeculae. For example, superior and inferior vertebrae in thespine can be beneficially stabilized by the injection of an appropriate,curable material (e.g., polymethylmethacrylate (PMMA) or other bonecurable material). In other procedures, percutaneous injection undercomputed tomography (CT) and/or fluoroscopic guidance of stabilizationmaterial into vertebral compression fractures by, for example,transpedicular or parapedicular approaches, has proven beneficial inrelieving pain and stabilizing damaged bone sites. Other skeletal bones(e.g., the femur) can be treated in a similar fashion. In any regard,bone in general, and cancellous bone in particular, can be strengthenedand stabilized by a palliative injection of bone-compatible material.

Using a vertebropasty as a non-limiting example, a conventionaltechnique for delivering the bone stabilizing material entails placing acannula with an internal stylet into the desired injection site. Thecannula and stylet are used in conjunction to pierce the cutaneouslayers of a patient above the hard tissue to be supplemented, then topenetrate the hard cortical bone of the vertebra, and finally totraverse into the softer cancellous bone underlying the cortical bone.Once positioned in the cancellous bone, the stylet is then removedleaving the cannula in the appropriate position for delivery of curablematerial to the trabecular space of the vertebra to reinforce andsolidify the damaged hard tissue.

According to one method in the prior art, curable material, isintroduced into an end of the cannula for delivery into the vertebrausing a 1 cc syringe. A 1 cc syringe is used because it generates thehigh pressures required to the force curable material through thecannula and into the vertebra. A disadvantage of a 1 cc syringe is thatan amount of curable material required for the procedure is larger than1 cc. As a result, it is required to sterilely reload the syringeseveral times during the procedure. This increases time and complexityof the procedure and increases the risk of radiation exposure to thephysician.

An improved prior art procedure uses a curable material injector loadedwith a relatively larger volume of curable material. The injector isconnected to an end of the cannula via a non-compliant supply tube.Pressure created at the injector pushes a column of curable materialthrough the supply tube and into the cannula. Curable material is thendelivered from the cannula into the trabecular space of the vertebra.Although an improvement over the use of a syringe, the method hasseveral disadvantages.

The method results in less control for the physician because the flow ofcurable material through the cannula has been found to be somewhatunpredictable. A column of curable material is pushed by substantialpressure over a distance, creating a pressure head in the column. Whenthe curable material column reaches the end of the cannula, physicianshave experienced that the curable material can burst into the trabecularspace, depositing an uncontrolled volume of curable material in anuncontrolled manner. Further, the transfer of curable material from theinjector to the vertebra can only begin after the supply tube isconnected to the cannula. A significant amount of time can elapse whilethe column of curable material is advanced through the supply tube andcannula.

Moreover, during a long procedure, curable material can begin tosolidify inside of the cannula. After the desired amount of curablematerial is deposited in the vertebra, the cannula is removed at thecompletion of the procedure. The curable material that was in thecannula that may have begun to set may remain attached to the core ofcurable material in the bone. As the cannula is removed, the curablematerial may break inside of the cannula instead of at the tip of thecannula and leave a “spike” of curable material protruding from thevertebra.

There exists a need in the medical device field for an improvedsubcutaneous bone material delivery system. The present inventionprovides an efficient device and method of introducing curable material,or other material, into a bone structure in a controlled manner.

BRIEF SUMMARY

One aspect of the present invention is directed to an apparatus forintroducing material into an injection site of a patient. The apparatusincludes a cannula defining a lumen. The apparatus also includes acarrier for delivering material from an injector to an injection site.The carrier defines a lumen and includes a supply section operable toreceive curable material, and an inner section having an axis anddefining a tip section operable to direct material in a direction thatis not coaxial with the axis of the inner section. In the apparatus, thecarrier is releasably attachable with the cannula, and at least aportion of the inner section is located within the lumen of the cannula.

In another aspect of the present invention, an apparatus is provided forintroducing material into an injection site of a patient. The apparatushas an injector containing a volume of material, a cannula having anelongated portion defining a lumen wherein an end of the elongatedportion is for positioning within the injection site and a carrierdefining a lumen between the injector and the injection site. Thecarrier further includes a supply tube having a first end adaptable forconnecting the supply tube with the injector and receive material fromthe injector and a second end. The carrier also includes a connectorattaching the carrier with the cannula. The connector also defines achamber. The carrier also includes an inner tube having a first end anda second end, wherein the connector connects the second end of thesupply tube with the first end of the inner tube via a chamber such thatthe supply tube, chamber and inner tube form a lumen having asubstantially smooth transition from the supply tube to the inner tube.In the apparatus, at least a portion of the inner tube is located withinthe lumen of the elongated portion of the cannula.

In yet another aspect of the present invention, a method of deliveringmaterial to the injection site is provided. The method includes a stepof inserting a cannula defining an elongated lumen into an injectionsite. The method also includes a step of connecting a carrier defining alumen with an injector containing a volume of material. The methodfurther includes a step of pre-loading the lumen of the carrier with thematerial so that the material is delivered to a distal end of thecarrier from the injector, wherein the carrier is thus pre-loaded withmaterial. The method also includes a step of inserting at least aportion of the distal end of the pre-loaded carrier into the elongatedlumen of the cannula and delivering material to an injection site.

In another aspect of the present invention, a method of deliveringmaterial to the injection site is provided. The method includes a stepof inserting a cannula defining an elongated lumen into an injectionsite. The method also includes a step of connecting a carrier with aninjector containing a volume of material, said carrier defining a lumenand comprising an inner section distal from the injector. The methodfurther includes a step of inserting at least a portion of the distalinner section of the carrier into the elongated lumen of the cannula.The method also includes a step of transmitting material from theinjector through the lumen of the carrier wherein curable material isalso transmitted through the distal inner section. The method finallyincludes a step of delivering material to an injection site.

Advantages of the present invention will become more apparent to thoseskilled in the art from the following description of the preferredembodiments of the invention which have been shown and described by wayof illustration. As will be realized, the invention is capable of otherand different embodiments, and its details are capable of modificationin various respects. Accordingly, the drawings and description are to beregarded as illustrative in nature and not as restrictive.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of the curable material delivery deviceaccording to a preferred embodiment of the present invention prior toinsertion of the inner section into the cannula;

FIG. 2 is a cross-section view of the curable material delivery deviceaccording to a preferred embodiment of the present invention afterinsertion of the inner section into the cannula;

FIG. 3 is a cross-section view of the curable material delivery deviceaccording to another preferred embodiment of the present invention afterinsertion of the inner tube into the cannula;

FIG. 4 is a cross-section of the connection between the supply tube andthe cannula according to a preferred embodiment of the presentinvention;

FIG. 4 a is a cross-section of the inner section according to apreferred embodiment of the present invention;

FIG. 5 is a cross-section of the connection between the supply tube andthe cannula according to a another preferred embodiment of the presentinvention;

FIG. 5 a is a cross-section view of the curable material delivery deviceaccording to another preferred embodiment of the present invention;

FIG. 5 b is a cross-section view of the curable material delivery deviceaccording to another preferred embodiment of the present invention;

FIG. 5 c is a cross-section view of the curable material delivery deviceaccording to another preferred embodiment of the present invention;

FIG. 6 is a perspective view of the curable material delivery deviceaccording to a preferred embodiment of the present invention afterinsertion of the inner section into the cannula;

FIG. 7 is a perspective view of the tip portion of the curable materialdelivery device according to a preferred embodiment of the presentinvention;

FIG. 8 is a perspective view of the tip portion of the curable materialdelivery device according to another preferred embodiment of the presentinvention;

FIG. 9 is a perspective view of the tip portion of the curable materialdelivery device according to another preferred embodiment of the presentinvention; and

FIG. 10 is a perspective view of the curable material delivery deviceaccording to a preferred embodiment of the present invention.

DETAILED DESCRIPTION OF THE DRAWINGS AND THE PRESENTLY PREFERREDEMBODIMENTS

FIG. 1 illustrates components of an intraosseous, curable materialdelivery system 5 according to principles of the present invention. Thecurable material delivery system 5 according to a preferred embodimentof the present invention has an injector 10, a carrier assembly 20connected to the injector 10 via an injection connector 110 and acannula 30 for insertion into a bone site of interest in a patient. Inthe embodiment depicted in FIG. 1, the bone site of interest is avertebra 40.

Details on the various components are provided below. In general terms,however, a portion of the carrier assembly 20 is sized to be slidablydisposed within the cannula 30 that otherwise serves to form and/orlocate a desired injection site within a bone. Once positioned withinthe cannula, the carrier assembly 20 is employed to inject a curable,bone stabilizing material into the delivery site. The system 5 can beused for a number of different procedures, including, for example,vertebroplasty and other bone augmentation procedures in which curablematerial is delivered to a site within bone, as well as to remove oraspirate material from a site within bone.

The system 5, and in particular the carrier assembly 20, is highlyuseful for delivering a curable material in the form of a bone cementcurable material. The phrase “curable material” within the context ofthe substance that can be delivered by the system/device of theinvention described herein is intended to refer to materials (e.g.,composites, polymers, and the like) that have a fluid or flowable stateor phase and a hardened, solid or cured state or phase. Curablematerials include, but are not limited to injectable bone cements (suchas polymethylmethacrylate (PMMA) bone curable material), which have aflowable state wherein they can be delivered (e.g., injected) by acannula to a site and subsequently cure into hardened curable material.Other materials, such as calcium phosphates, bone in-growth material,antibiotics, proteins, etc., could be used in place of or to augment,bone cement (but do not affect an overriding characteristic of theresultant formulation having a flowable state and a hardened, solid orcured state). This would allow the body to reabsorb the curable materialor improve the clinical outcome based on the type of filler implantmaterial.

The injector 10 may typically comprise a chamber filled with a volume ofcurable material and uses any suitable injection system or pumpingmechanism to transmit curable material out of the injector and throughthe carrier assembly 20. Typically, a hand injection system is usedwhere a physician applies force by hand to an injector. The force isthen translated into pressure on the curable material to flow out of thechamber. A motorized system may also be used to apply force.

A cannula 30 is provided to be positioned in an injection site fordelivery of curable material therein. The cannula 30 is preferably madeof a surgical grade of stainless steel, but may be made of knownequivalent materials which are both biocompatible and substantiallynon-compliant at operating pressures described herein. The cannula 30defines a lumen 325 to allow the stylet (not shown), carrier assembly20, and other equipment to pass through the cannula 30. Preferably, atleast a distal end 330 of the cannula 30 is radiopaque. The cannula 30has an inside diameter which is only slightly larger than the outsidediameter of the stylet. The distal end 330 of the cannula 30 ispreferably beveled to ease the penetration of the cannula through thecutaneous and soft tissues, and especially through the hard tissues.

Surrounding the proximal end 328 of the cannula 30 is a handle 310 formanipulating the cannula 30 and connecting the cannula 30 with carrierassembly 20 via a handle connector 312. Preferably, handle connector 312has a Luer-lock type of connector, but other known connecting mechanismsmay be successfully interchanged, e.g., a conventional threaded hole, athread and locking nut arrangement, etc. Cannulas may be of standardlengths and diameters. A cannula may be about 4 cm to about 20 cm longand is preferably 12 cm long. Additionally, with respect to the cannuladiameter, the cannula may be about 1.2 mm in outer diameter (18 gauge)with a wall thickness of about 0.216 mm to about 5.2 mm in outerdiameter (6 gauge) with a wall thickness of about 0.381 mm, and ispreferably about 3.1 mm in outer diameter (11 gauge) with a wallthickness of about 0.33 mm or about 2.1 mm in outer diameter (13 gauge)with a wall thickness of about 0.305 mm.

The carrier assembly 20 provides a passageway for curable material totravel from the injector 10 to an injection site, such as a vertebra 40.With reference to FIG. 2, carrier assembly 20 preferably defines a lumen100 from the injection connector 110 to its terminal end 144 positionedinside of a patient. According to one preferred embodiment, the carrierassembly 20 comprises an injection connector 110, a cannula connector130 and a transfer body 115. The transfer body 115 further comprises asupply section 120 and an inner section 140. The injection connector 110is preferably a Luer-lock type of connector, but other known connectingmechanisms suitable for medical applications may be successfullyinterchanged.

The cannula connector 130 is fixedly attached to the transfer body 115and connects the carrier assembly 20 with the cannula 30 and cannulahandle 310. According to a preferred embodiment, the cannula connector130 contains a Luer-lock threaded fitting 200 for connection with aLuer-lock threaded fitting 300 of the cannula 30 to allow the carrierassembly 20 and cannula 30 to be removably detachable.

The transfer body 115 is preferably a single tubular structure thatdefines lumen 100. Due to the operating pressures required to transfercurable material through the carrier assembly 20, the transfer body 115is preferably made of a non-compliant material such aspolyetheretherketone (PEEK). Other suitable materials include aluminumor wire reinforced plastic. The supply section 120 of the transfer body115 is operable to receive curable material from the injector 10 and isgenerally defined by the section of the transfer body 115 between theinjector 10 and the cannula connector 130. The inner section 120 of thetransfer body 115 is operable to deliver curable material to aninjection site and is generally defined by the section of the transferbody 115 between the cannula connector 130 and the terminal end 144 ofthe carrier assembly 20 for positioning within the patient. At least aportion of the inner section 140 is adapted to be inserted into thecannula 30. The inner section 140 must therefore have an outer diameterthat is smaller than the inner diameter of the cannula 30; however, theouter diameter should not be so small so as to allow curable material totravel around the outside of the inner section 140 and back into thecannula 30. Preferably the clearance between the inner diameter of thecannula 30 and the outer diameter of the inner section 140 is within arange of about 1 to 30 thousandths of an inch and is more preferably nomore than about 5 thousands of an inch.

Additionally, according to a preferred embodiment the distal end 330 ofthe cannula 30 extends beyond the terminal end 144 of the inner section140 such that the terminal end 144 of the inner section 140 is at alength from the distal end 330 of the cannula 30 that is less than 50%of the length of the cannula 30. According to another preferredembodiment, the terminal end 144 of the inner section 140 issubstantially even with the distal end 330 of the cannula 30. Oneskilled in the art will also understand that an inner section 140 thatextends beyond the distal end 330 of the cannula 30 may also be used aslong as the inner section 140 fits within the injection site anddispenses curable material effectively.

One skilled in the art will appreciate that although this embodimentuses a single tube for delivering curable material to the patient, thesingle tube may be manufactured to have different diameters at differentsections of the tube.

With reference to FIG. 3, in another preferred embodiment, the supplysection 120 and inner section 140 may be separate structures that areconnected at the cannula connector 130. In this embodiment, preferablythe supply section 120, cannula connector 130 and inner section 140define the lumen 100. The supply section 120 has a first end 122 andsecond end 124 and is preferably a tubular structure that defines aportion of the lumen 100. Due to the operating pressures required totransfer curable material through the carrier assembly 20, the supplysection 120 is preferably made of a non-compliant material such aspolyetheretherketone (PEEK) or other polymer. Other suitable materialsinclude aluminum or wire reinforced plastic. The second end 124 of thesupply section 120 connects with a first end 132 of the cannulaconnector 130.

The inner section 140 comprises a first end 142 connected with thecannula connector 130 and a terminal end 144 for positioning within thepatient to deliver curable material to an injection site. The innersection 140 is adapted to be inserted into the cannula and preferablyextends from the cannula connector 130 to the injection site. Due to theoperational pressures applied with injecting curable material, the innersection 140 is preferable made of a non-compliant material and is morepreferably made of polyetheretherketone (PEEK) or aluminum. The innersection 140 must therefore have an outer diameter that is smaller thanthe inner diameter of the cannula 30; however, the outer diameter shouldnot be so small so as to allow curable material to travel around theoutside of the inner section 140 and back into the cannula 30.Preferably the clearance between the inner diameter of the cannula 30and the outer diameter of the inner section 140 is within a range ofabout 1 to 30 thousandths of an inch and is more preferably no more thanabout 5 thousands of an inch. The supply section 120 and the innersection 140 may be made of the same or different materials.

According to one preferred embodiment of the inner section 140, theinterior surface of the inner section 140 is smooth to aid in deliveryof material to a delivery site. Typical medical cannulas or needles inthe prior art for introducing curable material contain rough innersurfaces. Rough inner surfaces may have root-mean-square (RMS) values of50 micro inches and greater. It has been observed that the applicationof curable material requires relatively less force when the surfacesdefining the lumen for introducing the curable material are smooth.Smooth surfaces may have root-mean-square (RMS) values of about 45 andlower. As a result, in a preferred embodiment, the RMS value of theinner section defining lumen 100 has an RMS value of between about 0 andabout 45. In another preferred embodiment, the RMS value is preferablybetween about 0 and about 32, and is more preferably between about 0 andabout 16.

FIG. 4 a depicts an inner section 140 having a smooth interior surface141 defining a portion of lumen 100. In one preferred embodiment, theinterior surface 141 of the inner section 140 is coated with a drylubricant, such as Teflon®. In another preferred embodiment, asmooth-surface liner having a smooth interior surface 141 may be placedwithin the inner section 140 such the smooth-surface liner covers theinterior surface of the inner section 140. According to one preferredembodiment, the smooth-surface liner is made of Teflon®. In anotherpreferred embodiment, the interior surface 141 of inner section 140 ismanufactured to have a polished or mirror surface finish such that theinterior surface 141 of the inner section 140 has a substantially smoothsurface finish having an RMS value of 45 or lower. In this embodiment,the inner section 140 is preferably made of metal and is more preferablymade of stainless steel.

Additionally, according to a preferred embodiment the distal end 330 ofthe cannula 30 extends beyond the terminal end 144 of the inner section140 such that the terminal end 144 of the inner section 140 is at alength from the distal end 330 of the cannula 30 that is less than 50%of the length of the cannula 30. According to another preferredembodiment, the terminal end 144 of the inner section 140 issubstantially even with the distal end 330 of the cannula 30. Oneskilled in the art will also understand that an inner section 140 thatextends beyond the distal end 330 of the cannula 30 may also be used aslong as the inner section 140 fits within the injection site anddispenses curable material effectively.

In this embodiment, in addition to connecting the carrier assembly 20with the cannula 30, the cannula connector 130 also connects the supplysection 120 with the inner section 140. According to a preferredembodiment, the supply tube 120 connects with the cannula connector 130via a Luer-lock type of connector 210, but other known connectingmechanisms suitable for medical applications may be successfullyinterchanged. The cannula connector 130 further comprises a second Luerconnection 312 for connecting the inner section 140 with the cannulaconnector 130.

With reference to FIG. 4, the cannula connector 130 preferably comprisesa flangeless adapter 220. Flangeless adapter 220 provides a precise andsmooth transition from the supply section 120 to the inner section 140.It has been found that disruptions in the walls defining the lumen 100,such as at abrupt transitions in fittings or connections, can causecurable material within the lumen 100 to prematurely set and potentiallyplug the line. As a result, a smooth transition at fittings orconnections between lines advantageously delivers curable material tothe patient.

Preferably, flangeless adapter 220 defines a first radial lip 230, achamber 240, and a second radial lip 250. The chamber 240 furtherdefines an input end 242, an output end 244 and a transition region 246.To effect a precise and smooth transition from the supply section 120 tothe chamber 240, the second end of the supply section 124 abuts with thefirst radial lip 230 at the input end 242 of the chamber 240. The inputend 242 of the chamber has an inner diameter that is substantially thesame inner diameter of the supply section 120. Similarly, the first end142 of the inner section 140 abuts with the second radial lip 250 at theoutput end 244 of the chamber 240. The output end 244 of the chamber 240has an inner diameter that that is substantially the same as the innerdiameter of the inner section 140. It will thus be appreciated that aprecise and smooth transition between the supply section and the innersection is achieved.

In the embodiment depicted in FIG. 4, the supply section 120 and theinner section 140 have the same inner diameter. As a result the inputend 242, transition region 246 and output end 244 of the chamber alsohave the same diameter. In another preferred embodiment, the supplysection 120 and the inner section 140 may have different innerdiameters. Accordingly, the input end 242 and output end 244 of thechamber 240 will also have different inner diameters. In thisembodiment, the transition region 246 of the chamber 240 is tapered tosmoothly transition the chamber 240 from one diameter to the other.

It has been observed that the application of curable material is morecontrollable where the downstream pathway of the curable material ismore narrow than the upstream pathway. As a result, according to apreferred embodiment, the inner diameter of the inner section 140 issmaller than the inner diameter of the supply section 120. In thispreferred embodiment, the transition region 246 will preferably smoothlytransition the chamber 240 from a larger diameter at the input end 242of the chamber to a smaller diameter at the output end 244 of thechamber. It is important to keep in mind that abrupt transitions inconnections should be avoided to prevent plugging by the curablematerial. The flangeless adapter 220 is preferably made of a materialthat can withstand the operational pressures such aspolyetheretherketone (PEEK) or other polymers.

With reference to FIG. 5, another embodiment of the cannula connector ispresented. In this embodiment the supply section 120 and the innersection 140 are conveniently detachable from each other such thatdifferent inner sections 140 may be attached and detached from thesupply section 120. In this embodiment, the inner section 140 comprisesan inner section connector 480. The inner section connector 480 connectswith the cannula connector 130 via the Luer-lock connection 200 that wasused to connect to the cannula handle 310 in the previous embodiment.The inner section connector 480 also comprises another Luer-lockconnection 475 for connection to the cannula handle 310. The innersection connector 480 further comprises a second flangeless adapter 420to provide a precise and smooth transition from the cannula connector130 to the inner section 140. With reference to FIG. 5, preferably thesecond flangeless adapter 420 defines a chamber 440 and a radial lip450. The chamber 440 further defines an input end 442, an output end 444and a transition region 446. To effect a precise and smooth transitionfrom the cannula connector 130 to the chamber 440, the output end 477 ofthe chamber 240 of the cannula connector 130 abuts with the input end442 of the second chamber 440. The input end 442 of the second chamber440 has an inner diameter that is substantially the same inner diameterof the output end 477 of the chamber 240 of the cannula connector 130.It will be appreciated that multiple sizes of inner sections may beattached to a single sized supply section because each inner sectionconnector contains a particularly tapered transition region 446 that issuitable to smoothly transition the supply section 120 with an innersection 140.

With reference to FIG. 5 a, another embodiment of the cannula connectoris presented. In this embodiment the supply section 120 (not shown) andthe inner section 140 are conveniently detachable from each other suchthat different inner sections 140 may be attached and detached from thesupply section 120. Additionally, in this embodiment the supply section120 is conveniently rotatable with respect to the inner section 140 suchthat the material injector and supply section 140 may be rotated aroundthe longitudinal axis of the inner section 140 to achieve a preferredorientation for ease of use. In this embodiment, the inner section 140is connected with a connector body 680. The connector body 680 connectsvia a Luer-lock connection 628 to the cannula handle 310 (see FIG. 1).The connector body 680 also comprises fixed adapter 690 and a rotatingadapter 620. The rotating adapter 620 allows a rotatable transition fromthe supply section 120 to the inner section 140 via the connecter body680. In this embodiment, the rotating adapter 620 is operative to rotatewith respect to the fixed adapter 690 and to rotate about thelongitudinal axis of the inner section 140. The rotating adapter 620 isoperative to interface with the supply section 120 and allow the supplysection 120 to rotate during use. In a preferred embodiment, therotating adapter is operative to rotate the supply section preferablyabout 90 degrees and more preferably about 360 degrees.

With reference to FIG. 5 a, according to one preferred embodiment therotating adapter 620 defines a grip section 622, a holder section 624and a cap 626. In one preferred embodiment the grip section 622 andholder section 624 are connected with each other by an adhesive;however, in another embodiment, the grip and holder sections may beintegrally formed. The holder 624 section is inserted into a cavity inthe fixed adapter 690 and the cap 626 is placed over the end of thefixed adapter 690 to secure the holder section 624 within the fixedadapter 690. According to one preferred embodiment, the cavity of thefixed adapter 690 also contains an O-ring 692 to interface with theholder section 624. The grip section 622 preferably contains one or morefin-like projections 630 to aid in rotating the rotating adapter 620.The grip section 622 also contains a Luer threading 628 operative toconnect the supply section 120 to the connecter body 680. Whenassembled, the connecter body 680, inner section 140 and supply section120 form a lumen to allow material to be delivered from the materialinjector to the material delivery site.

In another embodiment of the connector body 680, connector body 680further comprises a flangeless adapter (not shown) in accordance withthe flangeless adapters described herein to provide a precise and smoothtransition from the supply section 120 to the inner section 140. It willalso be appreciated that because the inner section is detachable fromthe supply section, multiple sizes of inner sections may be attached toa single sized supply section.

According to another preferred embodiment, the inner section 140 alsorotates as the rotating adapter 620 is rotated. In this embodiment,rotation of the supply section 120 causes the inner section 140 torotate to provide for directional delivery of curable material withinthe injection site. With reference to FIG. 5 b, according to onepreferred embodiment the inner section 140 is connected to the rotatingadapter 620. As can be seen in FIG. 5 b, the inner section 140 extendsthrough the fixed adapter 680 to the rotating adapter 620. The innersection 140 and rotating adapter 620 may be connected by an adhesive;however, other connection means may be used. According to one preferredembodiment, an end 691 of the inner section 140 may be flared tocorrespond with a surface of the rotating adapter 620 to aid inmanufacturing of the invention and to increase surface area for anadhesive. In this embodiment, the supply section 120 is connected withthe rotating adapter as described above. As the supply section isrotated about the longitudinal axis of the inner section 140, the innersection is also rotated within and relative to the fixed adapter 690.Thus, rotation of the inner section 140 is dependant on rotation of thesupply section. When used with various inner section tip configurations,rotation of the supply section will cause rotation of inner section andprovide for directional application of curable material within theinjection site.

According to yet another preferred embodiment, the inner section 140 andthe supply section 140 can rotate independently of each other. In thisembodiment, the supply section 120 may be rotated about a thelongitudinal axis of the inner section 140 without causing the innersection 140 to rotate. Additionally, the inner section 140 may berotated to provide directional cement delivery without rotating thesupply section 120. With reference to FIG. 5 c, in this embodimentrotating adapter 620 is connected with a second connector body 780. Thesecond connector body 780 connects to the rotating adapter 620 via Luerthread 628. The second connector body 780 also comprises a second fixedadapter 790 and a second rotating adapter 720. The second rotatingadapter 720 allows an independent rotatable transition from the supplysection 120 to the inner section 140. In this embodiment, the secondrotating adapter 720 is operative to rotate with respect to the secondfixed adapter 790 and to rotate about the longitudinal axis of the innersection 140. The second rotating adapter 720 is operative to interfacewith the supply section 120 and allow the supply section 120 to rotateduring use.

With continued reference to FIG. 5 c, according to one preferredembodiment the second rotating adapter 720 defines a second grip section722, a second holder section 724 and a second cap 726. In one preferredembodiment the second grip section 722 and second holder section 724 areconnected with each other by an adhesive; however, in anotherembodiment, the grip and holder sections may be integrally formed. Thesecond holder section 724 is inserted into a cavity in the second fixedadapter 790 and the second cap 726 is placed over the end of the secondfixed adapter 790 to secure the second holder section 724 within thesecond fixed adapter 790. According to one preferred embodiment, thecavity of the fixed adapter 690 also contains a second O-ring 792 tointerface with the second holder section 724. The second grip section622 preferably contains one or more fin-like projections 730 to aid inrotating the second rotating adapter 720. The second grip section 722also contains a Luer threading 728 operative to connect the supplysection 120 to the second connecter body 780. When assembled, theconnecter body 680, second connecter body 780, inner section 140 andsupply section 120 form a lumen to allow material to be delivered fromthe material injector to the material delivery site.

In this embodiment, the inner section 140 may be rotated using therotating adapter 620 independently of rotation of the supply section120. When used with various inner section tip configurations, rotationof the inner section 140 will provide for directional application ofcurable material within the injection site.

Regardless of an exact configuration, the assembled curable materialdelivery system (such as the curable material delivery system 5 ofFIG. 1) in accordance with principles of the present invention is highlyuseful in performing a wide variety of bone stabilizing procedures aspart of an overall curable material delivery system. Using avertebroplasty as a non-limiting example, in operation, the cannula 30and stylet (not shown) are driven into the vertebra 40 to reach thetrabecular cavity of the vertebra 40. The stylet is removed, leaving anopen lumen 325 within the cannula 30. Curable material is mixed andloaded into the injector 10. Preferably, curable material is transferredunder pressure from the injector 10 to the terminal end 144 of the innersection 140 prior to insertion of the inner section 140 into the lumen325 of the cannula 30. In practice, an operator may advance curablematerial beyond the terminal end 144 of the inner section 140 in orderto completely fill the inner section 140 and then wipe the terminal end144 of the inner section 140 of excess curable material before insertioninto the cannula 30. The carrier assembly is thus preloaded with curablematerial before the carrier assembly 20 is connected with the cannula 30and the inner section 140 is inserted into the cannula 30. Once theinner section 140 is inserted into the cannula 30 and the carrierassembly 20 is connected with the cannula 30, curable material isimmediately available to be delivered into the vertebra 40. Thispreloading step advantageously reduces the time required to delivercurable material into a patient because it can be done at substantiallythe same time the cannula 30 is being driven into the vertebra. In theprior art, the transfer of curable material from the injector can beginonly after a supply tube is connected with the cannula. Time is thusrequired to transfer curable material from the injector to the supplytube, through the cannula tube, and into the patient. In the preferredembodiment of the present invention, however, curable material ispreloaded to the terminal end 144 of the inner section 140 and the innersection 140 is then inserted into the cannula 30, thus making curablematerial immediately available to be delivered to the patient. Oneskilled in the art will realize, however, that curable material need notbe preloaded into the carrier assembly to realize other advantages onthe present invention.

It has been observed that during the initial preloading of the deliverydevice with curable material, a “dry plug” forms at the end of thecurable material column as it advances through the device. The dry plugis formed when monomer is extracted from the leading end of the columnof curable material as it coats the inner surface of the delivery devicelumen. As monomer is extracted from the curable material the end of thecolumn becomes dry and increases friction against the inner surface. Thedry plug becomes longer as the column of curable material is advancedwhich, in turn, further increases friction.

The dry plug thus requires the injector to exert greater pressure toadvance the column of curable material when compared with a column thatdoes not have a dry plug. As a result, according to one preferredembodiment a preferred method may be employed to reduce the effects ofthe dry plug during preloading. According to this preferred method ofpreloading the curable material delivery device, the inner section 140is detached from the supply section 120 and curable material is loadedto the distal end of the supply section 120. The curable material isthen further advanced so that the dry plug is dispelled from the distalend of the supply section 120. The distal end of the supply section 120is then wiped clean of any excess curable material and the inner section140 is attached to the supply section 120. Preloading of the curablematerial continues as described above.

At this point in the procedure, the inner section 140 is inserted intothe cannula 30 and locked into place with the Luer-lock that connectsthe carrier assembly 20 to the cannula 30 in order to prohibit ejectionof the carrier assembly 20 from the cannula 30 under pressure. Thepresent invention permits burst-free injection of the curable materialinto an injection site at the beginning of the procedure because thecarrier assembly 20 is primed prior to insertion into the cannula 30.When the physician activates the injector 10, the curable material isalready going into the injection site and hence the flow is morepredictable. The injector will then allow transfer of finely controlledamounts of curable material into the patient.

Following the delivery of a predetermined amount of curable materialinto the vertebra, the carrier assembly 20 may be detached from thecannula 30 and removed. It will be appreciated by one skilled in the artthat when the carrier assembly 20 is removed, the inner section 140,which is loaded with curable material, is also removed and thus removesthe column of curable material from the cannula 30. Several advantagesare therefore realized in this embodiment. First, because the innersection 140 functions as a liner between the curable material and thecannula 30, there is no residual curable material inside of the cannula30. The cannula 30 may therefore again be used to deliver additionalmaterial to the vertebra. Second, in the prior art, curable material maybegin to set within the cannula 30 before completion of the procedure.When the procedure is complete and the cannula is removed, the resultingcurable material column may break at a point inside the cannula 30 andnot at the tip of the distal end 330 of the cannula 30. This results ina “spike” of curable material that is still attached to the curablematerial that has been deposited inside of the vertebra and the “spike”may extend outside of the vertebra. In the present invention, it hasbeen observed that the curable material more uniformly breaks at the tipof the terminal end 144 of the inner section 140 when the inner section140 is removed, thus minimizing the opportunities for curable material“spikes.” Additionally, it is understood in the art that curablematerial will begin to set more quickly when exposed to bodytemperature. In the present invention, if delivery of curable materialneeds to be interrupted for a period of time, the inner section 140 canbe conveniently temporarily removed from the cannula 30 and cooled bythe relatively cooler room temperature, slowing the setting of thecurable material. This is not possible under the prior art where curablematerial filled within the cannula 30 cannot be removed during theoperation.

The present invention also allows a physician to conveniently fillmultiple cannulas in one or more vertebra with curable material in thesame operation. It is understood that a physician may enter a vertebralbody with two basic approaches: uni-pedicular and bi-pedicular. In theuni-pedicular approach, the physician attempts to place the cannula insuch a way that it traverses the midline of the vertebral body. This isdone so that the entire vertebra can be filled through one entry pointand one cannula. This technique can provide faster curable materialfilling, thus reducing procedure time. The technique, however, can betechnically more challenging for the physician and may not always bepossible to use. The bi-pedicular approach relies on placing a cannulathrough each pedicle of a vertebra. Because there is no need to traversethe midline of the vertebral body, the bi-pedicular approach isconsidered technically easier and safer. It permits equal filling onboth sides of the vertebra, thus providing more uniform distribution ofcurable material.

The present invention can be used with both the uni-pedicular andbi-pedicular approaches. In the bipedicular approach the same carrierassembly 20 can be used to fill a first side of a vertebral body througha first cannula until the first side is satisfactorily filled. The innersection 140 of the carrier assembly 20 can then be removed from thefirst cannula and positioned within a second cannula to the other sideof the vertebral body. It will be appreciated that upon removal of thecarrier assembly 20, the first cannula is substantially free of curablematerial. It will also be appreciated that the inner section 140 isstill filled with curable material and is thus “preloaded” with respectto the second procedure. Filling of the second side of the vertebralbody can therefore immediately begin while the curable material beginsto set on the first side. If the physician so desires, he or she canreturn to the first cannula and resume filling the first side. In apreferred embodiment, the physician can alternate between first andsecond cannula in a procedure, keeping both clean.

In another preferred embodiment, the physician may fill two differentvertebral bodies in one procedure. The technique allows the physician towork between cannulas at various times while keeping the cannulas clean.In this embodiment, the physician drives cannulas into two or morevertebra. The carrier assembly 20 is preloaded with curable material asdescribed above. The carrier assembly 20 is connected with the firstcannula 30 for the first procedure and curable material is immediatelydelivered to the vertebra. At the completion of the first procedure, thecarrier assembly 20 is removed from the first cannula 30. It will beappreciated that the inner section 140 is still filled with curablematerial and is thus “preloaded” with respect to the second procedure.The carrier assembly 20 is connected to the second cannula 30 andcurable material is ready to be immediately delivered to the vertebra.

Alternative structures may be employed within the scope of the presentinvention. With reference to FIG. 6, in another preferred embodiment,the terminal end 144 of the inner section extends beyond the distal end330 of the cannula 30. The tip portion 550 of the terminal end 144 cancontain different configurations to deliver curable material to aninjection site.

In a preferred embodiment shown in FIG. 7, the tip portion 550 containsa closed, blunt end 518 such that the terminal end 144 is axially closedto the lumen 100 (i.e., material cannot be axially expelled from theterminal end 144 relative to an axis of the lumen 100). That is to say,material in the lumen 100 cannot be forced distally therefrom in anaxial fashion. Further, the terminal end 100 defines or includes a bluntend 518. In one embodiment, the blunt end 518 defines a hemisphericalsurface, although other blunt (i.e., curved or curvilinear) shapes orcontours are also acceptable. The blunt end 518 is adapted to provide anon-traumatic surface suitable for accessing, contacting and probingbone or tissue while minimizing the risk of puncture and/or coring ofthe tissue or damage to the bone.

The tip portion 550 also defines a side orifice 520 formed adjacent theterminal end 144, extending through a thickness of a sidewall of the tipportion 550. The side orifice 520 can assume a wide variety of shapesand sizes. For example, the side orifice 520 can be oval, circular,curvilinear, etc. In one embodiment, a chamfered region 570 can beformed about the side orifice 520 to eliminate sharp edges along anexterior of the tip portion 550 as well as to promote consistent flow ofcurable material from the side orifice 520 (via the expanding orificesize effectuated by the chamfered region 570). Although the tip portion550 has been described as including or otherwise forming one sideorifice 520, two, circumferentially aligned side orifices can beprovided

With reference to FIGS. 8-9, a variety of other configurations for thetip portion 550 are also acceptable. FIG. 8 shows a tip portion 550having three side orifices 522 having consecutively smaller sideorifices. This reduction in side orifice size proximal the terminal end144 promotes consistent distribution of curable material otherwise beingforced through the tip portion 550. While three of the side orifices 522are shown, other configurations are also acceptable. For example,multiple side orifices (i.e., more than three side orifices) can beformed longitudinally along the length of the tip portion 550, and inaddition, the side orifices can include more than one longitudinallyaligned series of side orifices. In an exemplary embodiment, the sideorifices that are visible in FIG. 8 are matched by another column oflongitudinally aligned side orifices formed on an opposing side of thetip portion 550 (and therefore not visible in the view of FIG. 8).Aspects of the present invention provide for the side orifices 522 todefine circular side orifices, non-circular side orifices, or a set ofcircular and non-circular side orifices.

FIG. 9 shows another preferred embodiment of the tip portion 550. Inthis embodiment, the tip portion 550 is bent to provide about a 90degree opening 560 with respect to the axis of the inner section 140. Inthe exemplary embodiment, the angle between the opening 560 and the axisof the inner section, represented by θ, is 90 degrees. Aspects of thepresent invention contemplate that the angle θ may be between 0 and 90degrees and are preferably substantially 90 degrees. Preferably, theleading edge of the tip portion 550 should be substantially rounded sothat the tip portion 550 does not easily cut into tissue. In oneembodiment, the inner section comprises a rotatable hub that rotates theinner section 140. The hub would comprise a visual indicatorcorresponding to the orientation of the opening 560 so that theclinician may visualize the opening at the terminal end of the innersection. Preferably, the hub of the inner section has a seal to allowthe hub to be rotated 360 degrees. Therefore, the clinician can orientcement injection in any direction based upon the architecture of thearea that the bone cement in injected into.

With reference to FIG. 10, another preferred embodiment of the presentinvention comprises a curved portion 510 at the terminal end 505 of theinner section that extends beyond the distal end of the cannula 30during a procedure. In this embodiment, the curved portion 510 is aresilient preformed curved section capable of being straightened forinsertion through the elongated tubular portion of the cannula. Thecurved portion also has a shape memory feature which allows it to returnto its curved shape after exiting the distal end of the elongatedtubular portion. The curved portion 510 may be formed integrally withthe inner section or may be a separate structure that is bonded with theinner section. In a preferred embodiment, a visual indicator, such as asymbol or color indicator on the cannula connector, for example, isprovided to indicate to the physician the orientation of the curvedportion 510 relative to the cannula connector. The inner section 140includes indicia 517 adjacent the terminal end 144. The indicia 517 isindicative of a location of the terminal end 144 relative to the distalend of the cannula 30. The indicia 517 can assume a wide variety offorms differing from that shown in FIG. 10, and in some embodiments canbe eliminated. The end portion 550 may be any of the tip configurationsdescribed above.

In operation, a cannula is positioned within a vertebral body asdescribed above. The carrier assembly having the curved portion 510 ispreloaded with curable material and inserted into the elongated tubularportion of the cannula. Depth indicia 517 on the inner section may beused by the physician to determine how far the curved portion 510 hastraveled beyond the distal end of the cannula 30. After the desireddepth is achieved, curable material may be delivered to the vertebralbody. Using the visual indicator of the orientation of the curvedportion 517, the curved portion 515 may be repositioned so that curablematerial may be delivered to different areas within the vertebral body.Following the delivery of a predetermined amount of curable materialinto the vertebra, the carrier assembly 20 is removed from the cannula30.

It is also contemplated that according to another preferred embodiment,the invention may be used with a tamping operation using an inflatabledevice. Tamping operations using a balloon are known in the prior artand are disclosed at, for example, U.S. Pat. No. 4,969,888, titled“Surgical Protocol for Fixation of Osteoporotic Bone Using InflatableDevice” and U.S. Pat. No. 5,108,404, titled “Surgical Protocol ForFixation of Bone Using Inflatable Device.” In those procedures in whichphysicians believe a clinical advantage can be gained by tamping theinternal bone, the present invention may be used in the followingmanner. First, a physician gains entry into the bone using a cannula andstylet combination. After gaining entry, the trabecular bone ismorcellated to create a void for the tamping device. The tamping deviceis inserted into this space and expanded, thus enlarging the void in thebone. After the tamping device is removed, the preloaded inner sectionis inserted into the cannula and curable material is delivered into thesite as already described.

It is therefore intended that the foregoing detailed description beregarded as illustrative rather than limiting, and that it be understoodthat it is the following claims, including all equivalents, that areintended to define the spirit and scope of this invention. In thisregard, it should be understood that although reference to bone sitesand curable material has been made, the devices and methods disclosedherein are not limited in application to bone sites and curablematerials. One skilled in the art will understand that the devices andmethods disclosed herein may be used at non-bone sites such as spinaldiscs and may be used to inject material other than curable material.

INDUSTRIAL APPLICABILITY

The system and method answers a long felt need for increasing safety andcontrol in the administration of curable material to a bone site byproviding an inner section of tubing within a cannula that may bepreloaded with curable material. The inner section of tubing allows acannula to remain free of the curable material so that it may be reusedduring the procedure. Additionally, preloading the inner section oftubing with curable material allows for reduced time to deliver curablematerial to a patient and increases control over the curable materialdelivery.

1. An apparatus for introducing material into an injection site of apatient comprising: a cannula defining a lumen; a carrier assembly fordelivering material from an injector to an injection site, the carrierassembly defining a carrier lumen and the carrier assembly comprising aninjection connector; a cannula connector; a supply section and an innersection, detachable from the supply section and configured to beproximal to the patient, the inner section having a longitudinal axis,where the supply section is operable to receive curable material,wherein a supply section portion distant from the inner section extendsnon-coaxially from the inner section such that the supply sectionportion distant from the inner section is revolvable around thelongitudinal axis of the inner section, where a supply section near theinner section is rotatable around the longitudinal axis of the innersection, and where at least a portion of the inner section is locatedwithin the lumen of the cannula.
 2. The apparatus of claim 1 wherein theinner section is rotatable and rotation of the inner section isdependent on rotation of the supply section.
 3. The apparatus of claim 1wherein the inner section is rotatable and rotation of the inner sectionis independent of rotation of the supply section.
 4. The apparatus ofclaim 1 wherein the carrier further comprises a connector for connectingan end of the supply section with an end of the inner section whereinthe connector defines a chamber between the end of the supply sectionand the end of the inner section.
 5. The apparatus of claim 4 whereinthe connector further comprises a rotating adapter that connects withthe end of the supply section.
 6. The apparatus of claim 5 wherein therotating adapter is operative to rotate the supply section not less thanabout 90 degrees.
 7. The apparatus of claim 6 wherein the supplysection, chamber and inner section form a lumen having walls defining asubstantially smooth transition from the supply section to the innersection.
 8. A method of delivering material to an injection sitecomprising the steps of: providing an apparatus according to claim 1,wherein the supply section is configured as a tubular supply sectiondefining a lumen, and the inner section is configured as a tubular innersection; inserting the cannula into an injection site; connecting thetubular supply section with an injector containing a volume of material;advancing material through the tubular supply section from the injectora sufficient distance to dispel a dry plug of material from the tubularsupply section; connecting the tubular inner section of the carrier withthe supply section; pre-loading the lumen of the carrier with thematerial so that the material is delivered to a distal end of thetubular inner section from the injector, wherein the carrier is thuspre-loaded with material; inserting at least a portion of the distal endof the pre-loaded tubular inner section into the elongated lumen of thecannula; and delivering material to an injection site.
 9. The method ofclaim 8 wherein the injection site and a second injection site arewithin a vertebra.
 10. The method of claim 9 wherein the tubular supplysection and the tubular inner section are of different diameters.